Trial of Lenvatinib Plus PembrolizumAb in Recurrent Gynecological Clear Cell Adenocarcinomas (LARA)

Summary

This is a phase II non-randomized, multi-center study. The primary end point of this study is the objective response rate (ORR) at 24 weeks, using response evaluation criteria for solid tumors (RECIST) 1.1 criteria, for the combination therapy of continuous daily oral lenvatinib with three-weekly intravenous pembrolizumab in patients with recurrent clear cell carcinoma of gynecological origin (CCGC). The statistical design is Simon's minimax two-stage design and the present study aims to complete stage 1 of the Simon's two-stage design.

Timeline

Start

2021-02-18

Primary completion

2024-01

Completion

2025-01

Publications

• Results del Carmen MG, Birrer M, Schorge JO. Clear cell carcinoma of the ovary: a review of the literature. Gynecol Oncol. 2012 Sep;126(3):481-90. doi: 10.1016/j.ygyno.2012.04.021. Epub 2012 Apr 21.
• Results Brinton LA, Felix AS, McMeekin DS, Creasman WT, Sherman ME, Mutch D, Cohn DE, Walker JL, Moore RG, Downs LS, Soslow RA, Zaino R. Etiologic heterogeneity in endometrial cancer: evidence from a Gynecologic Oncology Group trial. Gynecol Oncol. 2013 May;129(2):277-84. doi: 10.1016/j.ygyno.2013.02.023. Epub 2013 Feb 26.
• Ngoi NYL, Lee JY, Lim D, Thian YL, Lim YW, Chan JJ, Chay WY, Zhang Z, Gopinathan A, Lim SE, Low J, Ng J, Tong P, Lee YJ, Park J, Kim JW, Tan TZ, Zhu J, Tai BC, Choi CH, Kim BG, Tan DSP. Pembrolizumab plus lenvatinib in recurrent gynaecological clear cell carcinoma (LARA): a multicentre, single-arm, phase 2 trial. Lancet Oncol. 2026 Feb;27(2):201-211. doi: 10.1016/S1470-2045(25)00662-X. Epub 2026 Jan 15.

Drugs

Indications